BEFORE THE PATENT TRIAL AND APPEAL BOARD TISSUE …knobbemedical.com/.../2014/12/IPR-Petition-for-U.S.... · Petitioners are the real parties-in-interest for this petition. B. Standing

IN THE UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

TISSUE TRANSPLANT TECHNOLOGY LTD. &

HUMAN BIOLOGICS OF TEXAS, LTD. Petitioners

v. MIMEDX GROUP, INC.

Patent Owner

U.S. Patent No. 8,597,687 to Daniel Issue Date: December 3, 2013

Title: METHODS FOR DETERMINING THE ORIENTATION OF A TISSUE GRAFT

Inter Partes Review No. __________________

PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 8,597,687 UNDER 35 U.S.C. §§ 311–319 and 37 C.F.R. §§ 42.100 ET SEQ.

Mail Stop PATENT BOARD Patent Trial and Appeal Board U.S. Patent and Trademark Office P.O. Box 1450 Alexandria, Virginia 22313–1450

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TABLE OF CONTENTS

I. INTRODUCTION ......................................................................................... 1

II. NOTICES AND DISCLOSURES ................................................................ 1

Real Party-In-Interest ......................................................................... 1 A.

Standing Certification ......................................................................... 1 B.

Related Matters .................................................................................... 2 C.

Petitioners’ Counsel ............................................................................. 2 D.

Service Information ............................................................................. 2 E.

Payment of Fees .................................................................................... 2 F.

III. PERSON OF ORDINARY SKILL IN THE ART ...................................... 2

IV. STATEMENT OF PRECISE RELIEF ....................................................... 3

Overview of the ’687 Patent ................................................................ 3 A.

1. The ’687 Patent Discloses Labeling a Placental Tissue Graft to

Distinguish a First Side from a Second Side ..................................................... 3

2. Priority Date of the ’687 Patent ........................................................ 4

3. File Wrapper Analysis of the ’687 Patent ......................................... 4

Claims at Issue ...................................................................................... 7 B.

Construction of Relevant Claim Terms ............................................. 8 C.

1. “user” ................................................................................................ 8

2. “asymmetric” ..................................................................................... 9

3. “label” ............................................................................................... 9

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4. “placing an asymmetric label on a portion” ..................................... 9

5. “for application” ............................................................................... 9

6. “ascertaining the orientation” .......................................................... 9

7. “embossment” .................................................................................. 10

8. “raised or indentured texture” ........................................................ 10

9. “design” ........................................................................................... 10

10. “basement side” ............................................................................... 10

11. “stromal side” ................................................................................. 10

State of the Art on or Before August 17th, 2005. ............................ 11 D.

Nomenclature of the Industry ........................................................... 12 E.

Petitioner Seeks Cancellation of all Claims of the ’687 Patent ..... 13 F.

V. GROUNDS FOR UNPATENTABILITY .................................................. 13

Standard for Obviousness ................................................................. 13 A.

Ground 1. Claims 1-4, 6, and 7 are Obvious Under 35 U.S.C. § B.103(a) over Nigam ............................................................................. 15

Ground 2. Claims 1, 3, 4, 6, and 7 are Obvious Under 35 U.S.C. § C.103(a) over Dua .................................................................................. 19

Ground 3. Claims 1-4, 6 & 7 are Obvious Under 35 U.S.C. § 103(a) D.over Nigam in view of Dua ............................................................... 27

Ground 4. Claims 1-7 are Obvious Under 35 U.S.C. § 103(a) over E.Nigam in view of Hariri .................................................................... 32

Ground 5. Claims 1-7 are Obvious Under 35 U.S.C. § 103(a) over F.Dua in view of Hariri ........................................................................ 39

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VI. CONCLUSION ............................................................................................ 46

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EXHIBITS

EXHIBIT NAME ABBREVIATION

BBA1001 U.S. Pat. No. 8,597,687, issued December 3, 2013

’687 Patent

BBA1002 Declaration of Daniel L. Mooradian, Ph.D. Mooradian Declaration

BBA1003 Selected Excerpts of the Prosecution History of the ’687 Patent

’687 Patent Prosecution History

Excerpts

BBA1004 U.S. Pat. Publ. No. 2001/0056303, published Dec. 27, 2001

Caneiro

BBA1005 WEBSTER’S ENCYCLOPEDIC UNABRIDGED

DICTIONARY OF THE ENGLISH LANGUAGE 129 (1996).

Definition of Asymmetric.


DICTIONARY OF THE ENGLISH LANGUAGE

1926 (1996).

Definition of Symmetry.

BBA1007 Thesaurus.com, Label, http://www.thesaurus.com/browse/label (last visited November 21, 2014).

Synonyms of Label.



Definition of Ascertain.



Definition of Emboss.



1964 (1996).

Definition of Texture.

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1238 (1996). Definition of Mold.

BBA1012 Thesaurus.com, Design, http://www.thesaurus.com/browse/design (last visited November 21, 2014).

Synonyms of Design.

BBA1013 U.S. Pat. No. 6,581,993, issued June 24, 2003 Nigam

BBA1014 H. S. Dua et al., Amniotic Membrane Transplantation, 83 BR. J. OPTHALMOLOGY 748 (1999)

Dua

BBA1015 U.S. Pat. Publ. No. 2004/0048796, published Mar. 11, 2004

Hariri

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I. INTRODUCTION

Tissue Transplant Technology Ltd. (d/b/a Bone Bank Allografts) & Human

Biologics of Texas, Ltd. (collectively “Petitioners”) petition for Inter Partes

Review (“IPR”), seeking cancellation of claims 1 - 7 of U.S. Patent No 8,597,687

(“’687 Patent”) which is owned MiMedx Group, Inc. (“MiMedx”).

All elements of claims 1 - 7 are obvious as explained below in the proposed

grounds of unpatentability. The institution of an IPR requires a threshold showing

of “a reasonable likelihood that the petitioner [will] prevail with respect to at least

one of the claims challenged in the petition.” 35 U.S.C. § 314(a). This Petition

meets that threshold.

II. NOTICES AND DISCLOSURES

Real Party-In-Interest A.

Petitioners are the real parties-in-interest for this petition.

Standing Certification B.

Petitioners certify that the ’687 Patent is available for IPR. Petitioners are

not barred or estopped from requesting an IPR challenging the claims of the ’687

Patent on the grounds identified in this petition. Furthermore, this petition is filed

within one year of Petitioners being served the identified below patent

infringement lawsuit.

2

Related Matters C.

MiMedx, the Patent Owner, filed a lawsuit against the Petitioners asserting

infringement of claims 1, 3, 4, 6, and 7 of the ’687 Patent and claim 9 of U.S. Pat.

No. 8,709,494 (’494 Patent). The lawsuit, Case No. 1:14-CV-719-HLH, was filed

May 16, 2014 and is currently pending in the Western District of Texas, San

Antonio Division. Petitioner previously filed an IPR against the ’494 Patent.

Petitioners’ Counsel D.

Lead Counsel Back-up Counsel Robert L. McRae (Reg. No. 53,309)

GUNN, LEE & CAVE, P.C. 300 Convent St., Suite 1080

San Antonio, TX 78205 (210) 886-9500 (Voice) (210) 886-9883 (Fax)

[email protected]

Jason E. McKinnie (Reg. No. 65,726) GUNN, LEE & CAVE, P.C. 300 Convent St., Suite 1080

San Antonio, TX 78205 (210) 886-9500 (Voice) (210) 886-9883 (Fax)

[email protected]

Service Information E.

Please address all correspondence and service to the address of both counsel

listed above. Petitioner consents to electronic service by email at

[email protected] and [email protected].

Payment of Fees F.

The required fee is paid via online credit card payment.

III. PERSON OF ORDINARY SKILL IN THE ART

A person of ordinary skill in the art (“POSITA”), as of the priority date of

the ‘687 Patent, is an M.D. or clinician that uses tissue implants in surgical

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procedures or a person with a Ph.D. or Master’s degree education with knowledge

of surgical procedures, implantation technique and the requirements of a surgeon

(user) who would use tissue implants. A POSITA as of the priority date of the

‘687 Patent would likely have an M.D. degree with surgical training and/or a Ph.D.

(or at least Master of Science) degree in chemistry, biochemistry, biology, cell

biology, or a medical science degree in pathology or medicine. Declaration of

Daniel L. Mooradian, Ph.D [BBA1002] at ¶ 15. When used in this report, the term

POSITA refers to the ordinary skill as of the priority date of the ’687 patent.

IV. STATEMENT OF PRECISE RELIEF

Overview of the ’687 Patent A.

1. The ’687 Patent Discloses Labeling a Placental Tissue Graft to Distinguish a First Side from a Second Side

The claimed subject matter of the ’687 Patent concerns the placement of an

asymmetric label on a placental tissue graft. BBA1001. The asymmetric label

permits a clinician to directly and visually distinguish between the stromal side and

basement membrane side of the placental tissue graft. According to the claimed

subject matter, the asymmetric label exists in multiple forms including an

embossment or raised or indented texture. Further, the asymmetric label may be a

logo, design, name, or text. In the claimed invention the label itself is asymmetric.

’687 Patent Prosecution History Excerpts [BBA1003] at 14. It is not required that

the label be asymmetrically placed on the placental tissue graft. Id.

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Importantly, the claimed method does not dictate how the asymmetric label

is placed on the tissue graft. While the specification discloses a drying fixture, the

drying fixture is not a claimed element. As a result, the actual method of affixing

the label is not relevant for the ’687 Patent. BBA1003 at 22.

2. Priority Date of the ’687 Patent

The ’687 Patent was filed on August 7, 2012 as a continuation of U.S. Pat.

App. Ser. No. 11/840,728, filed on Aug. 17, 2007, now U.S. Pat. No. 8,372,437,

which claimed the benefit under 35 U.S.C. §119(e) of U.S. Provisional Pat. App.

No. 60/838,467 filed Aug. 17, 2006. BBA1003 at 50. The above applications were

expressly incorporated by reference in the ’687 Patent. Id. The ’687 Patent issued

on December 3, 2013. BBA1001. MiMedx claims a priority date of Aug. 17,

2006.

3. File Wrapper Analysis of the ’687 Patent

The originally filed independent claim of the ’687 Patent was significantly

narrowed before it was in condition for allowance. The originally filed

independent claim did not have an element requiring the tissue graft to be of

placental origin nor did it require the label itself be asymmetric. BBA1003 at 51.

Additionally, the originally filed claim did not include the requirement of the user

ascertaining the orientation by direct visual determination. Id.

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The USPTO initially rejected all claims of the ’687 Patent. BBA1003 at 18.

Two claims, including the only independent claim, were rejected under § 102

based on Caneiro. Id. Caneiro teaches construction of a prosthetic sheet that is

used in abdominal surgery. Caneiro [BBA1004] at ¶ 1. One side, or face, of the

prosthesis contains a smooth surface and the other face contains a discontinuous

textured surface. Id. at ¶¶ 17-18, Fig. 2. The discontinuous textured surface is

affixed to the smooth surface through adhesive, molding, or heat sealing. Id. at ¶

18. The Examiner construed the attachment of the discontinuous textured surface

as reading on the originally filed independent claim. BBA1003 at 21. Specifically,

the Examiner stated it corresponded to the claim language of “placing a label on a

portion of at least one side of said tissue graft.” Id.

The Examiner additionally rejected all the claims under § 103 in view of

Bilbo. BBA1003 at 22. According to the Examiner, Bilbo, a patent publication,

taught lamination of intestinal collagen layers (ICL) to form a tissue graft. Id. The

tissues had a “sidedness quality” that was relevant in some applications. Id. The

Examiner concluded “it would have been prima facie obvious to one having

ordinary skill in the art to include a visual label, such as a written mark, tag, or

colored feature on one side of said prosthesis in order to permit a surgeon at the

point of use to directly identify the different faces having the distinct properties.”

Id. at 23.

6

MiMedx sought to overcome the rejections through the following

amendment to the independent claim:

21. (Currently amended) A method for permitting direct, visual

determination of the orientation of a placental tissue graft [[to]] by a

user, wherein the placental tissue graft has a first side and a second

side, said method comprising placing an asymmetric label on a

portion of at least one side of said tissue graft, which label visibly

distinguishes one side from the other side, thereby defining permitting

direct, visual determination of the orientation for application of said

tissue graft; and ascertaining the orientation of the placental tissue

graft by direct visual determination.

BBA1003 at 10. Notably, MiMedx’s amendment a) limits the tissue graft to

placenta tissue, b) requires the label itself to be asymmetric, and c) requires the

user be the one ascertaining the orientation of the graft by directly viewing the

label. Id. MiMedx argued there was no teaching in Bilbo that the “sidedness” of

the graft mattered, thus there is no reason to put a label on the tissue graft. Id. at

13-14. Furthermore, MiMedx states the sole reason a user is able to ascertain the

proper orientation is “because the label is asymmetric.” Id. at 14.

Ultimately the Examiner accepted the amendment and allowed the

application to issue. In the stated reasons for allowance, the Examiner noted the

“active step” of placing an asymmetric label on a placenta tissue graft was novel

and non-obvious. BBA1003 at 7. The Examiner acknowledged that placenta tissue

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inherently possessed a maternal side and a fetal side as disclosed by the prior art,

but that the prior art failed to disclose any use of a placenta tissue graft that

required a specific orientation. Id. The Examiner seemed to conclude that it

would not be obvious to include a label on placental tissue graft if the prior art

failed to teach a reason to distinguish the sides of the placenta tissue graft. Id.

Claims at Issue B.

1. A method for permitting direct, visual determination of the orientation of

a placental tissue graft by user, wherein the placental tissue graft has a first side

and a second side, said method comprising: placing an asymmetric label on a

portion of at least one side of said tissue graft, which label visibly distinguishes

one side from the other side, thereby permitting direct, visual determination of the

orientation for application of said tissue graft; and ascertaining the orientation of

the placental tissue graft by direct visual determination.

2. The method of claim 1, wherein said label is an embossment.

3. The method of claim 1, wherein said label is a raised or indented texture.

4. The method of claim 1, wherein said label is a logo, a design, a name, or

text.

5. The method of claim 1, wherein said tissue graft contains multiple tissue

layers.

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6. The method of claim 1, wherein said label visibly distinguishes a

basement side of the placental tissue graft.

7. The method of claim 1, wherein said label visibly distinguishes a stromal

side of the placental tissue graft.

Construction of Relevant Claim Terms C.

There are several terms/phrases of the ’687 Patent that should be construed.

“A claim in an unexpired patent shall be given its broadest reasonable construction

in light of the specification of the patent in which it appears.” 37 C.F.R.§

42.100(b). A claim term must be given its “ordinary and customary meaning [as

it] . . . would have to a person of ordinary skill in the art in question at the time of

the invention.” Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005); In re

Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2006); accord M.P.E.P.

§ 2111.01(I). All claim terms not specifically addressed below have been accorded

their broadest reasonable interpretation in light of the patent specification and its

plain and ordinary meaning to a POSITA.

1. “user”

A POSITA would define “user” as “a surgeon or clinician who uses the

tissue grafts in medical applications or surgical procedures.” BBA1001 at 2:10-14,

8:25-29; BBA1003 at 14; BBA1002 at ¶ 22.

9

2. “asymmetric”

A POSITA would define “asymmetric” as “lacking any mirror image

symmetry.” BBA1001 at 8:25-29; BBA1003 at 14; Definition of Asymmetric

[BBA1005]; Definition of Symmetry [BBA1006]; BBA1002 at ¶ 23.

3. “label”

A POSITA would define “label” as “an identifying mark.” BBA1001 at

2:33-36, Fig. 5; Synonyms of Label [BBA1007]; BBA1002 at ¶ 24.

4. “placing an asymmetric label on a portion”

A POSITA would define “placing an asymmetric label on a portion” as

“placing and identifying mark which lacks any mirror image symmetry on a

middle portion.” BBA1001 at 2:62-67, 8:25-29; BBA1002 at ¶ 25.

5. “for application”

A POSITA would define “for application” as “for use by a surgeon or

clinician who uses the tissue graft in medical applications or surgical procedures.”

BBA1001 at 2:10-14; BBA1002 at ¶ 26.

6. “ascertaining the orientation”

A POSITA would define “ascertaining the orientation” as “distinguishing

said first side from said second side by a surgeon or clinician who uses the tissue

graft in medical applications or surgical procedures.” BBA1001 at 2:27-33;

Definition of Ascertain [BBA1008]; BBA1002 at ¶ 27.

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7. “embossment”

A POSITA would define “embossment” as “a label raised in relief from a

surface.” BBA1001 at 2:27-30; Definition of Emboss [BBA1009]; BBA1002 at ¶

28.

8. “raised or indentured texture”

A POSITA would define “raised or indentured texture” as “molded tissue.”

BBA1001 at 8:15-25; Definition of Texture [BBA1010]; Definition of Mold

[BBA1011]; BBA1002 at ¶ 29.

9. “design”

A POSITA would define “design” as “a raised decorative or artistic

depiction.” BBA1001 at 2:62-67; Synonyms of Design [BBA1012]; BBA1002 at ¶

30.

10. “basement side”

A POSITA would understand the reference to the “basement side” in claim 6

as referring to the epithelial or fetal side of the placental tissue graft. BBA1001 at

1:39-41, 6:59-60; BBA1002 at ¶ 31.

11. “stromal side”

A POSITA would understand the reference to the “stromal side” in claim 7

as referring to the mesenchymal or maternal side of the placenta tissue graft.

BBA1001 at 6:57-59; BBA1002 at ¶ 32.

11

State of the Art on or Before August 17th, 2005. D.

A POSITA would have understood that tissue grafts from placental tissues

are naturally asymmetric having one surface that is interchangeably termed the

fetal, epithelial or basement side and another surface that is interchangeably called

the mesenchymal or stromal side. BBA1002 at ¶ 16.

A POSITA would also have known that the orientation of the sides of the

placental tissue grafts with respect to the implantation site (e.g., the cornea) was

important for purposes including ensuring proper graft adherence. BBA1002 at ¶

17.

A POSITA would have known that users of these grafts would therefore

have reason to distinguish the two sides of the tissue graft during a surgical

procedure. BBA1002 at ¶ 18.

A POSITA would also have known that users of these grafts had developed

a number of methods permitting one to distinguish the sides of placental tissue

grafts and that those methods included. BBA1002 at ¶ 19.

A POSITA would have understood that in addition to labeling methods

utilized by the surgeon at the time of surgery, methods incorporated into the

manufacture of these grafts including the application of a nitrocellulose membrane

to one side of the graft were possible. BBA1002 at ¶ 20.

12

A POSITA would understand the benefits of eliminating the need for the

surgeon to distinguish between the sides of the graft based on an assessment of the

grafts intrinsic asymmetry alone. BBA1002 at ¶ 21.

Nomenclature of the Industry E.

The ’687 Patent and the references identified below utilize varying

nomenclature that a POSITA would understand to mean the same or similar things.

The subject matter of the ’687 Patent concerns placental tissue grafts. The

specification of the ’687 Patent helps define the term placental tissue by stating

“[h]uman placental membrane (e.g. amniotic membrane or tissue).” BBA1001 at

1:25-26. For purposes of the ’687 Patent and the references cited, a POSITA

would understand that a tissue graft constructed of amniotic membrane is a

placental tissue graft as utilized in the ’687 Patent. BBA1002 at ¶ 33.

Furthermore, the placental tissue, including the amniotic membrane, has a

side that faces the fetus and a side that faces the mother. BBA1002 at ¶ 34. These

sides, especially for amniotic membrane, have a variety of names that refer to the

same side. Id. In the ’687 Patent, claims 6 and 7 disclose a basement side and a

stromal side. The basement side is also referred to as the epithelial side and/or

fetal side. Id. The stromal side is also referred to as the mesenchymal side and/or

maternal side. Id. The following chart identifies the term used in the ’687 Patent

13

and the corresponding term, as it would be understood by a POSITA, for the cited

references:

‘687 Patent Claim Term Dua Hariri

Claim 6 - Basement side Epithelial side Fetal side

Claim 7 - Stromal side Mesenchymal side Maternal side

Petitioner Seeks Cancellation of all Claims of the ’687 Patent F.

Petitioners requests an Inter Partes Review and cancellation of claims 1-7 of

the ’687 Patent. The chart below identifies the basis for cancellation of claims 1-7.

Petitioners’ full statement of the reasons for the relief requested is set forth in

detail in § V.

Ground Statutory

Basis Reference(s)

’687 Patent Claims

1 103(a) Nigam 1-4, 6, 7 2 103(a) Dua 1, 3, 4, 6, 7 3 103(a) Nigam in view of Dua 1-4, 6, 7 4 103(a) Nigam in view of Hariri 1-7 5 103(a) Dua in view of Hariri 1-7

V. GROUNDS FOR UNPATENTABILITY

Standard for Obviousness A.

A patent is invalid as obvious when “the differences between the claimed

invention and the prior art are such that the claimed invention as a whole would

14

have been obvious before the effective filing date of the claimed invention to a

person having ordinary skill in the art to which the claimed invention pertains.” 35

U.S.C. § 103(a); see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007).

An invention is obvious under KSR if the improvement claims no more than

“the predictable use of prior art elements according to their established functions.”

Id. at 417; MPEP § 2141. “[I]f a technique has been used to improve one device,

and a person of ordinary skill in the art would recognize that it would improve

similar devices in the same way, using the technique is obvious[,]” unless such use

would require skill beyond that of a person of ordinary skill in the art. KSR at 417.

Simply put, if a person of ordinary skill in the art implements a predictable

variation of the prior art, that variation is obvious. Id.

Rejecting the need for an explicitly stated motivation to combine prior art

elements, the Supreme Court in KSR held that in determining whether there was an

apparent reason to combine, the court should look to a variety of factors, including

but not limited to (1) the teachings of the prior art patents, (2) the effects of

marketplace demand, and (3) the background knowledge of a person of ordinary

skill in the art. Id. at 418. The court’s analysis should not rely solely upon explicit

teachings of the claimed subject matter, but also the inferences that a person of

ordinary skill in the art might exercise. Id.

15

Ground 1. Claims 1-4, 6, and 7 are Obvious Under 35 U.S.C. § B.103(a) over Nigam

Nigam is a U.S. Patent concerning an implant packaging and handling

system. Nigam [BBA1013]. The patent, issued on June 24, 2003, is more than one

year prior to the August 17, 2006 effective filing date of the ’687 Patent.

Accordingly, Nigam is prior art under § 103(a). Nigam was not identified in the

Information Disclosure Statement for the ’687 Patent. BBA1003 at 17, 27-32.

Nigam teaches a system for placing a lens implant on the surface of a

person’s cornea. The lens implant may be made of “various types of hydrogels,

but can include other polymers, tissue implants, or the like.” BBA1013 at 1:37-39

(emphasis added). Nigam teaches the placement of “special asymmetric

markings” “[t]o ensure that the implant is properly oriented.” Id. at 12:6-8. The

user, or the clinician, utilizes the asymmetrical markings to determine which side

should face the cornea for proper implantation. Id. at 12:8-10. Nigam further

describes the type of asymmetry necessary to achieve the desired goal through the

examples of placing letters such as the lowercase “a,” “R,” “P,” and “C” on the

posterior surface of the implant. Id. at 12:15-23. Nigam teaches that if the implant

is not placed with the correct side up, the letter will read backwards indicating the

orientation is not correct. Id. Nigam teaches that other asymmetric markings or

designs may be utilized to achieve this goal. Id. at 12:23-26. Nigam teaches the

16

asymmetric markings may be made onto the implant through laser engraving or

through printing with ink. Id. at 12:27-28.

It would be obvious to a POSITA to apply asymmetrical markings as taught

by Nigam to a placental tissue graft. BBA1002 at ¶ 41. Nigam expressly teaches a

lens implant may be constructed of “tissue.” BBA1013 at 1:37-39. It is well

known in the art that an ocular tissue implant may be, and commonly is,

constructed or manufactured of placenta tissue. BBA1002 at ¶ 41; see also Dua

[BBA1014]; Hariri [BBA1015] at Abstract. As such, it would be obvious to a

POSITA to utilize the label to visibly distinguish the basement side of the placental

tissue graft as well as the stromal side of the placental tissue graft. BBA1002 at ¶

17.

Nigam expressly teaches the label may be engraved into the tissue or printed

onto the tissue through use of ink. BBA1013 at 12:27-28. A POSITA would

understand the teaching of laser engraving to mean manipulation of the tissue itself

to create a contour or topography within the tissue. BBA1002 at ¶ 42. In contrast,

printing a label with ink does not necessarily physically manipulate the tissue. A

POSITA, in light of the laser engraving teachings of Nigam, would find it obvious

to use a variety of equivalent tissue manipulation methods to impart a label onto

the graft such as embossment and raised or indented texture. Id. Engraving,

embossing, and raised or indented texture are known to achieve similar purposes

17

and result in a manipulated tissue having a label. M.P.E.P § 2144.06(II) (citing

Smith v. Hayashi, 209 USPQ 754 (Bd. of Pat. Inter. 1980)).

The following chart identifies the specific disclosure of Nigam relating to

the limitations of claims 1-4, 6, and 7 that render the claims obvious. BBA1002 at

¶¶ 45-46.

CLAIMS NIGAM (BBA1013)

[Claim 1] A method for permitting direct, visual determination of the orientation of a placental tissue graft by user, wherein the placental tissue graft has a first side and a second side, said method comprising:

“To ensure that the implant is properly oriented, however, the implant is provided with special asymmetric markings, which the user views to make a determination that the implant is resting against the corneal surface in a proper orientation.” BBA1013 at 12:6-10.

placing an asymmetric label on a portion of at least one side of said tissue graft,

BBA1013 at Fig. 20.

18

“Referring to FIGS. 18-20, there are shown three examplary embodiments of asymmetric markings 94 that can be utilized to properly orient the lens implant. As shown by FIGS. 18 and 19, the markings are preferably positioned in a clockwise orientation. In another embodiment, shown in FIG. 20, a letter can be placed on the posterior surface of the implant.” BBA1013 at 12:10-16.

which label visibly distinguishes one side from the other side, thereby permitting direct, visual determination of the orientation for application of said tissue graft; and ascertaining the orientation of the placental tissue graft by direct visual determination.

“In this way, if the implant's posterior surface is placed onto the cornea surface, then the letter will not read properly. For instance, FIG. 20 shows the letter ‘a’ on the posterior surface of the implant 92. If the implant 92 is not positioned right side up on the cornea surface, then the letter will read backwards. In this embodiment, any letter can be used so long as it has an asymmetric design. For instance, ‘R’, ‘P’, ‘C’, etc.” BBA1013 at 12:16-23.

“the implant is provided with special asymmetric markings, which the user views to make a determination that the implant is resting against the corneal surface in a proper orientation.” BBA1013 at 12:6-10.

[Claim 2] The method of claim 1, wherein said label is an embossment.

“the markings 94 can be positioned onto the lens using laser engraving” BBA1013 at 12:27-28.

[Claim 3] The method of claim 1, wherein said label is a raised or indented texture.


19

[Claim 4] The method of claim 1, wherein said label is a logo, a design, a name, or text.

“In this embodiment, any letter can be used so long as it has an asymmetric design. For instance, ‘R’, ‘P’, ‘C’, etc.” BBA1013 at 12:21-23

[Claim 6] The method of claim 1, wherein said label visibly distinguishes a basement side of the placental tissue graft.

“In this way, if the implant's posterior surface is placed onto the cornea surface, then the letter will not read properly. For instance, FIG. 20 shows the letter "a" on the posterior surface of the implant 92. If the implant 92 is not positioned right side up on the cornea surface, then the letter will read backwards.” BBA1013 at 12:16-21.

[Claim 7] The method of claim 1, wherein said label visibly distinguishes a stromal side of the placental tissue graft.

“In this way, if the implant's posterior surface is placed onto the cornea surface, then the letter will not read properly. For instance, FIG. 20 shows the letter ‘a’ on the posterior surface of the implant 92. If the implant 92 is not positioned right side up on the cornea surface, then the letter will read backwards.” BBA1013 at 12:16-21.

Ground 2. Claims 1, 3, 4, 6, and 7 are Obvious Under 35 U.S.C. § C.103(a) over Dua

Dua is a printed publication concerning the utilization of amnion tissue

grafts in ophthalmology. Dua [BBA1014]. The article, published in 1999 in the

British Journal of Ophthalmology, is more than one year prior to the August 17,

2006 effective filing date of the ’687 Patent. Accordingly, Dua is prior art under

§ 103(a). Dua was not identified in any of the Information Disclosure Statements

submitted by the Applicant in the ’687 Patent. BBA1003 at 17, 27-32.

20

Dua describes how amniotic membrane, acquired from placenta, is utilized

in ophthalmology. Dua notes that amniotic membrane acts as a “transplanted

basement membrane” which promotes epithelialisation of the cornea and states that

in “some instances the amniotic membrane . . . acts as a ‘bandage contact lens’

allowing epithelialisation to occur under its cover.” BBA1014 at 748. Dua

expressly teaches that the amniotic membrane should be sutured to the surface of

the eye with the “epithelial side up and the mesenchymal surface in contact with

the eye, to facilitate adherence of the membrane to the ocular surface.” Id. at 750.

Dua further describes several surgical methods that permit the user or

clinician to distinguish between the two sides of the amniotic membrane prior to

implantation onto the surface of the eye. BBA1014 at 750-51. One technique

includes the use of applying a suture with a knot marking one side of the

membrane. Id. A second technique uses a pen to mark one side of the membrane.

Id. A third technique involves using blunt forceps to pinch each side of the

amniotic membrane and lift. Id. at 751. The pinching results in “[a] fine strand of

‘vitreous-like’ substance . . . from the mesenchymal [side] but not the epithelial

(basement membrane) side of the amniotic membrane.” Id. A fourth technique

occurs at the creation of the amniotic membrane as the membrane is mounted on

nitrocellulose with a predetermined side facing up. Id. at 750.

21

As an initial matter, a POSITA would know that a placental tissue graft as

claimed in the ’687 Patent would encompass the amniotic tissue graft disclosed in

Dua. BBA1002 at ¶ 54. Amnion is a component of the fetal membranes of

placenta as disclosed by Dua and the ’687 Patent. BBA1013 at 748; BBA1001 at

1:25-26. To the extent Applicant attempts to distinguish placenta from amnion, it

would be obvious to a POSITA that the methods of Dua would naturally apply to a

“placental” tissue graft. Id.

The claimed element of an asymmetric label would have been obvious to a

POSITA based on Dua’s four different techniques for labeling and distinguishing

the sides of the tissue graft. All four techniques constitute labels that permit a user

to distinguish one side from the other side as disclosed by the ’687 Patent.

BBA1002 at ¶¶ 54-64.

Although Dua does not expressly teach what type of mark would be made

with the indelible pen, it would have been obvious to a POSITA to utilize an

asymmetric mark. BBA1002 at ¶ 56. Considering the point of the mark is to

distinguish one side from the other, utilizing the capital letter “A” or “O” would

not make sense. Id. However, using an asymmetric letter such as “P” or “R”

would make sense and permit the user to distinguish one side from the other. Id.

Furthermore, it would be obvious to utilize a mark such as those identified in

Figure 5 of the ’687 Patent or to utilize a phrase, word, logo, design, or letter that is

22

readable when one side is facing up but backwards when the opposing side is

facing up. Id.

Dua’s teaching of a knot directly anticipates the claimed element of an

asymmetric mark or, at a minimum, accomplishes the same result. Some forms of

knots are asymmetric while others possess varying degrees of symmetry.

BBA1002 at ¶ 57. Dua does not disclose what type of knot is utilized but given the

teachings and the purpose behind the knot as taught by Dua, a POSITA would

understand that an asymmetric knot may be utilized to accomplish the purpose

disclosed by Dua. Id.

Furthermore, the use of a knot, the “fine strand of vitreous-like substance,”

and the mounting of nitrocellulose paper in a predetermined manner achieve the

same desired result of an asymmetric label. BBA1002 at ¶ 58. A POSITA would

understand that a knot and the “fine strand of vitreous-like substance” would

extend from one side of the placenta tissue graft. Id. The three dimensional nature

of that extension, or raised texture, would be readily seen by a user and would be

sufficient to distinguish one side from the other side. Id. The absence of a knot or

the “fine strand of vitreous-like substance” would similarly identify the opposing

side. Id. Similarly, the placement of the nitrocellulose paper specifically identifies

a designated side. The ’687 Patent expressly contemplates the three dimensional

nature of labels through disclosure of an embossment in claim 2 and raised or

23

indented texture in claim 3. It would be obvious to a POSITA to substitute the

asymmetric label of the ’687 Patent for a label having a three dimensional

component, such as a knot, a “fine strand of vitreous-like substance,” or affixing

nitrocellulose paper. The methods of Dua are equivalents to the asymmetric label

considering they are all capable of distinguishing the two sides of a placental tissue

graft. Id.; M.P.E.P § 2144.06(II) (citing Smith v. Hayashi, 209 USPQ 754 (Bd. of

Pat. Inter. 1980)).

Dua’s teaching of a knot and/or mark is sufficient to satisfy the elements of

claim 4. Claim 4 utilizes alternative limitations in stating the “label is a logo, a

design, a name, or text.” The use of alternative limitations in claims is permitted,

but “[w]hen a claim covers several structures or compositions, either generically or

as alternatives, the claim is deemed anticipated if any of the structures or

compositions within the scope of the claim is known in the prior art.” Brown v.

3M, 265 F.3d 1349, 1351 (Fed. Cir. 2001). A POSITA would have understood

Dua’s teaching of a knot and/or mark to be a design, logo, name, and/or text.

BBA1002 at ¶ 59.

Finally, Dua’s labeling of a side of the placental membrane tissue graft

obviously teaches the identification of the epithelial (basement) side and the

mesenchymal (stromal) side. BBA1002 at ¶ 60. A POSITA would understand

Dua’s reference to the epithelial side to correspond to the ’687 Patent’s reference

24

to the basement side in claim 6. Id. Similarly, a POSITA would understand Dua’s

reference to the mesenchymal side to correspond to the ’687 Patent’s reference to

the stromal side in claim 7. Id.

It is important to note that the Examiner allowed the ’687 Patent to issue, at

least in part, on the basis that no prior art disclosed a necessity for orienting a

placental tissue graft. BBA1003 at 7. Not only does Dua indicate a specific

orientation is necessary, but Dua teaches a method to distinguish between the two

sides.

The following chart identifies the specific disclosure of Dua relating to the

limitations of claims 1, 3, 4, 6, and 7 that renders the claims obvious. BBA1002 at

¶¶ 65-66.

CLAIMS DUA [BBA1014]

[Claim 1] A method for permitting direct, visual determination of the orientation of a placental tissue graft by user, wherein the placental tissue graft has a first side and a

second side, said method comprising:

“The [amniotic] membrane is always sutured to the ocular surface with its epithelial side up and the mesenchymal surface in contact with the eye . . . [f]or this reason it is important to be able to distinguish its two surfaces . . . [m]ost surgeons have developed a technique that suit them best . . .” BBA1014 at 750.

25

placing an asymmetric label

“use a suture, with the knot as the marker or indelible marker pen” BBA1014 at 750-51.

on a portion of at least one side of said tissue

graft, “to mark one side of the membrane.” BBA1014 at 751.

which label visibly distinguishes one side from the other side, thereby permitting

direct, visual determination of the

orientation for application of said

tissue graft; and ascertaining the

orientation of the placental tissue graft

by direct visual determination.

“The membrane is always sutured to the ocular surface with its epithelial side up and the mesenchymal surface in contact with the eye . . . For this reason it is important to be able to distinguish its two surfaces . . . Most surgeons have developed a technique that suits them best . . . Others will use a suture, with the knot as the marker or indelible marker pen, to mark one side of the membrane.” BBA1014 at 750-51.

[Claim 3] The method of claim 1, wherein

said label is a raised or indented texture.

“it is important to be able to distinguish its two surfaces . . . Most surgeons have developed a technique that suits them best . . . After spreading the membrane on the ocular surface we apply the tips of a blunt fine forceps to one surface of membrane and pinch lightly with the forceps and lift. A fine strand of ‘vitreous-like’ substance can usually be drawn up from the mesenchymal but not

26

the epithelial (basement membrane) side of the amniotic membrane.” BBA1014 at 750-51.

[Claim 4] The method of claim 1, wherein

said label is a logo, a design, a name, or

text.

“use a suture, with the knot as the marker or indelible marker pen to mark one side of the membrane.” BBA1014 at 750-51.

[Claim 6] The method of claim 1, wherein said label visibly distinguishes a

basement side of the placental tissue graft.

“The membrane is always sutured to the ocular surface with its epithelial side up and the mesenchymal surface in contact with the eye . . . For this reason it is important to be able to distinguish its two surfaces . . . Most surgeons have developed a technique that suits them best—for example, mounting the membrane on nitrocellulose paper, the right way up, so that the correct side can be determined when the membrane is thawed. Others will use a suture, with the knot as the marker or indelible marker pen, to mark one side of the membrane.” BBA1014 at 750-51.

[Claim 7] The method of claim 1, wherein said label visibly

distinguishes a stromal side of the placental

tissue graft.

“The membrane is always sutured to the ocular surface with its epithelial side up and the mesenchymal surface in contact with the eye . . . For this reason it is important to be able to distinguish its two surfaces . . . Most surgeons have developed a technique that suits them best—for example, mounting the membrane on nitrocellulose paper, the right way up, so that the correct side can be determined when the membrane is thawed. Others will use a suture, with the knot as the marker or indelible marker pen, to mark one side of the membrane.” BBA1014 at 750-51.

27

Ground 3. Claims 1-4, 6 & 7 are Obvious Under 35 U.S.C. § 103(a) D.over Nigam in view of Dua

Grounds 1 and 2 are incorporated by reference. A POSITA would have

combined the teachings of Nigam in view of Dua to render claims 1-4, 6 and 7 of

the ’687 Patent obvious. A POSITA would look to combining elements of Nigam

and Dua because both concern the surface orientation of tissue grafts in ophthalmic

uses and teach methods of distinguishing the two sides. BBA1002 at ¶ 72.

Specifically, Dua teaches a placental-based graft constructed of amnion while

Nigam is broader in application and covers “tissue implants.”

It would be obvious to a POSITA to combine the asymmetric label as

disclosed in Nigam to a placental tissue graft disclosed in Dua. BBA1002 at ¶ 74.

Dua teaches the use of a mark to distinguish the epithelial side from the

mesenchymal side and it would be obvious to combine the asymmetrical mark

taught by Nigam. Id. Furthermore, in light of the laser engraving teachings of

Nigam, and the three dimensional labels of Dua, a POSITA would find it obvious

to use a variety of tissue manipulation methods to impart a label onto the graft

including embossment and raised or indented texture. Id.

The following chart identifies the specific disclosure of Nigam and Dua

relating to the limitations of claims 1-4, 6, and 7 that renders the claims obvious.

BBA1002 at ¶¶ 75-76.

28

CLAIMS 1-4, 6, 7 DISCLOSURE

A method for permitting direct,

visual determination of

the orientation of a placental tissue graft by user, wherein the

placental tissue graft has a first side and a second side,

said method comprising:

DUA


NIGAM


placing an asymmetric label on a portion of at least one side of said tissue graft,

DUA

“use a suture, with the knot as the marker or indelible marker pen to mark one side of the membrane.” Dua at 751.” BBA1014 at 750-51.

NIGAM

29

BBA1013 at Fig. 20.


which label visibly distinguishes one

side from the other side, thereby

permitting direct, visual

determination of the orientation for application of said


orientation of the placental tissue graft by direct

visual determination.

DUA


NIGAM



[Claim 2] The NIGAM

30

method of claim 1, wherein said label is an embossment.


[Claim 3] The method of claim 1, wherein said label

is a raised or indented texture.

DUA

“it is important to be able to distinguish its two surfaces . . . Most surgeons have developed a technique that suits them best . . . After spreading the membrane on the ocular surface we apply the tips of a blunt fine forceps to one surface of membrane and pinch lightly with the forceps and lift. A fine strand of ‘vitreous-like’ substance can usually be drawn up from the mesenchymal but not the epithelial (basement membrane) side of the amniotic membrane.” BBA1014 at 750-51.

NIGAM


[Claim 4] The method of

claim 1, wherein said label is a logo, a design, a name,

or text.

DUA


NIGAM

“In this embodiment, any letter can be used so long as it has an asymmetric design. For instance, ‘R’, ‘P’, ‘C’, etc.” BBA1013 at 12:21-23.


visibly distinguishes a

basement side of the placental tissue

DUA

“The membrane is always sutured to the ocular surface with its epithelial side up and the mesenchymal surface in contact with the eye . . . For this reason it is important to be able to distinguish its two surfaces . . . Most surgeons have developed a technique that suits them best . . . Others will use a suture, with the knot as the marker or indelible marker

31

graft. pen, to mark one side of the membrane . . . A fine strand of “vitreous-like” substance can usually be drawn up from the mesenchymal but not the epithelial (basement membrane) side of the amniotic membrane.” BBA1014 at 750-51.

NIGAM




stromal side of the placental tissue

graft.

DUA

“The membrane is always sutured to the ocular surface with its epithelial side up and the mesenchymal surface in contact with the eye . . . For this reason it is important to be able to distinguish its two surfaces . . . Most surgeons have developed a technique that suits them best . . . Others will use a suture, with the knot as the marker or indelible marker pen, to mark one side of the membrane . . . A fine strand of “vitreous-like” substance can usually be drawn up from the mesenchymal but not the epithelial (basement membrane) side of the amniotic membrane.” BBA1014 at 750-51.

NIGAM


32

Ground 4. Claims 1-7 are Obvious Under 35 U.S.C. § 103(a) over E.Nigam in view of Hariri

Nigam is identified and discussed in Ground 1 and incorporated by

reference. Hariri is a U.S. Patent Publication directed to methods for preparation

and use of collagen biofrabrics made of placenta tissue. Hariri [BBA1015] at ¶¶ 7,

14. Hariri published on March 11, 2004 which is more than one year prior to the

August 17, 2006 effective filing date of the ’687 Patent. Accordingly, Hariri is

prior art under § 103(a). Hariri was disclosed in the Information Disclosure

Statement submitted by the Applicant in the ’687 Patent. BBA1003 at 27.

Hariri teaches the preparation of laminated collagen biofabrics or grafts

consisting of placental membranes. BBA1015 at ¶¶ 7, 14. Hariri specifically

teaches the use of amnion and/or chorion. Id. These collagen biofabrics may be

utilized for blood vessel repair, wound dressing, surgical grafts, and ophthalmic

uses among others. Id. at Abstract. Hariri’s specification teaches processing of

single layer biofabrics as well as “a laminate comprising at least two layers of the

biofabric.” Id. at ¶ 20. The preparation of the biofabric according to Hariri

includes drying the membrane with its fetal (basement) side up on a drying frame.

Id. at ¶ 20. Hariri’s preferred drying frame is a plastic mesh drying frame. Id. at ¶

20. Hariri teaches identification of the surface orientation of the membrane,

distinguishing the maternal side from the fetal side, by examining the grid pattern

created from the drying frame. Id. at ¶ 121. The fetal side will show as having a

33

concave or recessed grid pattern whereas the maternal side will show as having a

convex or elevated grid pattern. Id. at ¶ 121. Hariri teaches magnification may be

necessary to determine the surface orientation. Id. at ¶ 121.

It would have been obvious to a POSITA to combine the teachings of Nigam

with the teachings of Hariri. BBA1002 at ¶ 81. As stated supra, Nigam teaches the

need to distinguish sides of a tissue lens implant and includes asymmetric labels to

accomplish that task. Hariri expressly discloses use of its placental tissue

biofabrics for use in ophthalmology and a method to distinguish the sides of the

biofabric based on an embossed grid design.

Hariri teaches the concept of imparting or molding a design into placental

tissue that is capable of being viewed. Hariri’s disclosure of concave (indented)

and convex (raised) surfaces in the shape of a grid (design) falls within the scope

of claims 2, 3, and 4. While Hariri discloses these features as visible with a

microscope, it would be obvious to a POSITA to make the design visible without

the need for a microscope. BBA1002 at ¶ 80; Application of Rose, 220 F.2d 459,

463 (C.C.P.A. 1955) (finding that changing size of an object “is not ordinarily a

matter of invention”). In Application of Rose, the applicant sought to claim a

reduced size of an item as patentable because the prior art article needed a forklift

to move whereas Applicant’s claimed article may be lifted by hand. Application of

Rose, 220 F.2d 459, 463 (C.C.P.A. 1955). The Court of Customs and Patent

34

Appeals noted that “relative dimensions” among other items “are all deemed

matters of choice involving differences in degree and/or size and (are) not

patentable distinctions.” Id.

Considering Nigam teaches a form of tissue manipulation through laser

engraving of an asymmetric label, it would be obvious to a POSITA to utilize the

methods of Hariri to impart an asymmetric label of Nigam into tissue through

embossment or raised/indented texture. BBA1002 at ¶ 81. Engraving, embossing,

and raised or indented texture are known to achieve similar purposes and result in a

manipulated tissue having a label. M.P.E.P § 2144.06(II) (citing Smith v. Hayashi,

209 USPQ 754 (Bd. of Pat. Inter. 1980)). Furthermore, it would be obvious to

substitute the grid design, or add to the grid design, of Hariri, an asymmetrical

marking taught by Nigam as they would result in the same intended purpose – to

distinguish between the sides of the placental tissue graft. Id.

Furthermore, it would be obvious to impart an asymmetric label onto a tissue

graft having multiple layers. Hariri teaches creation of a multi-layered biofabric

laminate and teaches the ability to distinguish between sides. It would be obvious

to a POSITA to utilize the teachings of Nigam to label a placenta tissue graft

having more than one layer in view of Hariri. BBA1002 at ¶ 82.

35

The following chart identifies the specific disclosure of Nigam in

combination with Hariri relating to the limitations of claims 1 – 7 that renders the

claims obvious. BBA1002 at ¶¶ 83-84.

CLAIMS 1-7 DISCLOSURE






NIGAM


HARIRI

“[A] method of preparing a collagen biofabric from a placenta having an amniotic membrane and a chorionic membrane comprising: separating the amniotic membrane from the chorionic membrane” BBA1015 at ¶ 41.

“In a specific embodiment, the surface orientation of the collagen biofabric is identified under magnification. It will be appreciated by one skilled in the art that the fetal side of the collagen biofabric can be identified by its concave, i.e., recessed, grid pattern. Conversely, the maternal side can be identified by its convex, i.e., elevated grid pattern.” BBA1015 at ¶ 121.

placing an NIGAM

36

asymmetric label on a portion of at least one side of said tissue graft,

BBA1013 at Fig. 20.








visual

NIGAM



37

determination.


NIGAM


HARIRI

“Conversely, the maternal side can be identified by its convex, i.e., elevated grid pattern.” BBA1015 at ¶ 121.



NIGAM


HARIRI

“It will be appreciated by one skilled in the art that the fetal side of the collagen biofabric can be identified by its concave, i.e., recessed, grid pattern. Conversely, the maternal side can be identified by its convex, i.e., elevated grid pattern.” BBA1015 at ¶ 121.



or text.

NIGAM

“In this embodiment, any letter can be used so long as it has an asymmetric design. For instance, ‘R’, ‘P’, ‘C’, etc.” BBA1013 at 12:21-23.

HARIRI

The collagen biofabric of the invention has a "grid" pattern, which allows for the visual identification of the maternal and detal surfaces by one skilled in the art. BBA1015 at ¶ 121.

[Claim 5] The method of claim 1, wherein said tissue

graft contains multiple tissue

HARIRI

“[T]he invention provides a method of preparing an amniotic membrane laminate from a placenta having an amniotic membrane and a chorionic membrane comprising: separating

38

layers. the amniotic membrane from the chorionic membrane; decellularizing the amniotic membrane; and layering at least two of the decellularized amniotic membranes in contact with each other so that an amniotic membrane laminate is formed.” BBA1015 at ¶ 41.




graft.

NIGAM


HARIRI

“It will be appreciated by one skilled in the art that the fetal side of the collagen biofabric can be identified by its concave, i.e., recessed, grid pattern.” BBA1015 at ¶ 121.




graft.

NIGAM


HARIRI


39

Ground 5. Claims 1-7 are Obvious Under 35 U.S.C. § 103(a) over F.Dua in view of Hariri

Dua is identified and discussed in Ground 2 and incorporated by reference.

Hariri is a U.S. Patent Publication directed to methods for preparation and use of

collagen biofrabrics made of placenta tissue. Hariri [BBA1015] at ¶¶ 7, 14.

Hariri published on March 11, 2004 which is more than one year prior to the

August 17, 2006 effective filing date of the ’687 Patent. Accordingly, Hariri is

prior art under § 103(a). Hariri was disclosed in the Information Disclosure

Statement submitted by the Applicant in the ’687 Patent. BBA1003 at 27.

Hariri teaches the preparation of laminated collagen biofabrics or grafts

consisting of placental membranes. BBA1015 at ¶¶ 7, 14. Hariri specifically

teaches the use of amnion and/or chorion. Id. These collagen biofabrics may be

utilized for blood vessel repair, wound dressing, surgical grafts, and ophthalmic

uses among others. Id. at Abstract. Hariri’s specification teaches processing of

single layer biofabrics as well as “a laminate comprising at least two layers of the

biofabric.” Id. at ¶ 20. The preparation of the biofabric according to Hariri

includes drying the membrane with its fetal (basement) side up on a drying frame.

Id. at ¶ 20. Hariri’s preferred drying frame is a plastic mesh drying frame. Id. at ¶

20. Hariri teaches identification of the surface orientation of the membrane,

distinguishing the maternal side from the fetal side, by examining the grid pattern

created from the drying frame. Id. at ¶ 121. The fetal side will show as having a

40

concave or recessed grid pattern whereas the maternal side will show as having a

convex or elevated grid pattern. Id. at ¶ 121. Hariri teaches magnification may be

necessary to determine the surface orientation. Id. at ¶ 121.

Hariri teaches the concept of imparting or molding a design into placental

tissue that is capable of being viewed. Hariri’s disclosure of concave (indented)

and convex (raised) surfaces in the shape of a grid (design) falls within the scope

of claims 2, 3, and 4. While Hariri discloses these features as visible with a

microscope, it would be obvious to a POSITA to make the design visible without

the need for a microscope. BBA1002 at ¶ 90; Application of Rose, 220 F.2d 459,

463 (C.C.P.A. 1955) (finding that changing size of an object “is not ordinarily a

matter of invention”).

A POSITA would look to combine the elements of Dua and Hariri because

both teach utilization of labels to distinguish the basement and stromal sides of a

placental tissue graft; both utilize three-dimensional components for the labels, and

both labels achieve the same purpose of the asymmetric label of the ’687 Patent.

BBA1002 at ¶ 92. The three-dimensional nature of Dua’s labels, embossing of

Hariri, and raised or indented texture of Hariri are known to achieve similar

purposes as the ’687 Patent’s asymmetric label in that they all distinguish the sides

of a placental tissue graft. Thus the asymmetrical label of the ’687 Patent is

obvious. M.P.E.P § 2144.06(II) (citing Smith v. Hayashi, 209 USPQ 754 (Bd. of

41

Pat. Inter. 1980)). Furthermore, it would be obvious to substitute the grid design,

or add to the grid design, of Hariri, an asymmetrical marking taught by Nigam as

they would result in the same intended purpose – to distinguish between the sides

of the placental tissue graft. Id.

Dua’s teaching of a knot and/or mark as well as Hariri’s teaching of a grid is

sufficient to satisfy the elements of claim 4. Claim 4 utilizes alternative

limitations in stating the “label is a logo, a design, a name, or text.” The use of

alternative limitations in claims is permitted, but “[w]hen a claim covers several

structures or compositions, either generically or as alternatives, the claim is

deemed anticipated if any of the structures or compositions within the scope of the

claim is known in the prior art.” Brown v. 3M, 265 F.3d 1349, 1351 (Fed. Cir.

2001). A POSITA would have understood Dua’s teaching of a knot and/or mark to

be a design, logo, name, and/or text. BBA1002 at ¶ 59.

Furthermore, it would be obvious to a POSITA to impart a label onto a

tissue graft having multiple layers. BBA1002 at ¶ 94. Hariri teaches creation of a

multi-layered biofabric laminate and teaches the ability to distinguish between

sides. It would be obvious to a POSITA to utilize the teachings of Hariri and Dua

to label a placenta tissue graft having more than one layer. Id.

Finally, Hariri expressly teaches the labeling of the biofabric by stating the

fetal side will show a concave or recessed grid pattern whereas the maternal side

42

will show a convex or elevated grid pattern. BBA1015 at ¶ 121. Similarly, Dua

disclosing labeling of a side of the placental membrane tissue graft which

obviously teaches the identification of the basement (or epithelial side) and the

mesenchymal (or stromal side.) BBA1002 at ¶ 60. A POSITA would understand

Dua’s reference to the epithelial side and Hariri’s references to the fetal side as

corresponding to the ’687 Patent’s reference to the basement side in claim 6.

BBA1002 at ¶ 34. Similarly, a POSITA would understand Dua’s reference to the

mesenchymal side and Hariri’s reference to a maternal side as corresponding to the

’687 Patent’s reference to the stromal side in claim 7. BBA1002 at ¶ 34.

The following chart identifies the specific disclosure of Dua in combination

with Hariri relating to the limitations of claims 1 – 7 that renders the claims

obvious. BBA1002 at ¶¶ 95-96.

CLAIMS 1-7 DISCLOSURE






DUA


HARIRI

“In a specific embodiment, the surface orientation of the collagen biofabric is identified under magnification. It will be appreciated by one skilled in the art that the fetal side of

43

the collagen biofabric can be identified by its concave, i.e., recessed, grid pattern. Conversely, the maternal side can be identified by its convex, i.e., elevated grid pattern.” BBA1015 at ¶ 121.

placing an asymmetric label

DUA

“use a suture, with the knot as the marker or indelible marker pen” BBA1014 at 750-51.

on a portion of at least one side of said tissue graft,

DUA

“to mark one side of the membrane.” BBA1014 at 751.







visual determination.

DUA



HARIRI



DUA

“it is important to be able to distinguish its two surfaces . . . Most surgeons have developed a technique that suits them

44


best . . . After spreading the membrane on the ocular surface we apply the tips of a blunt fine forceps to one surface of membrane and pinch lightly with the forceps and lift. A fine strand of ‘vitreous-like’ substance can usually be drawn up from the mesenchymal but not the epithelial (basement membrane) side of the amniotic membrane.” BBA1014 at 750-51.

HARIRI

“It will be appreciated by one skilled in the art that the fetal side of the collagen biofabric can be identified by its concave, i.e., recessed, grid pattern. Conversely, the maternal side can be identified by its convex, i.e., elevated grid pattern.” BBA1015 at ¶ 121.



or text.

DUA


HARIRI

The collagen biofabric of the invention has a "grid" pattern, which allows for the visual identification of the maternal and detal surfaces by one skilled in the art. BBA1015 at ¶ 121.

[Claim 5] The method of claim 1, wherein said tissue

graft contains multiple tissue

layers.

HARIRI

“[T]he invention provides a method of preparing an amniotic membrane laminate from a placenta having an amniotic membrane and a chorionic membrane comprising: separating the amniotic membrane from the chorionic membrane; decellularizing the amniotic membrane; and layering at least two of the decellularized amniotic membranes in contact with each other so that an amniotic membrane laminate is formed.” BBA1015 at ¶ 41.

[Claim 6] The DUA

45

method of claim 1, wherein said label



graft.


HARIRI

“It will be appreciated by one skilled in the art that the fetal side of the collagen biofabric can be identified by its concave, i.e., recessed, grid pattern.” BBA1015 at ¶ 121.




graft.

DUA


HARIRI


46

VI. CONCLUSION

Petitioners respectfully requests that inter partes review of the ’687 Patent

be instituted and that claims 1 – 7 are found unpatentable for the reasons stated

above.

Dated: December 11, 2014 Respectfully submitted,

/Robert L. McRae, Reg. No. 53309/ Robert L. McRae, Reg. No. 53309

/Jason E. McKinnie, Reg. No. 65726/ Jason E. McKinnie, Reg. No. 65726

GUNN, LEE & CAVE, P.C. 300 Convent St., Suite 1080 San Antonio, TX 78205 Phone: (210) 886-9500 Fax: (210) 886-9883 Email: [email protected] Email: [email protected] ATTORNEYS FOR PETITIONERS

47

CERTIFICATE OF SERVICE

Pursuant to 37 C.F.R. §§ 42.8(b)(4) and 42.105(b), the undersigned certifies

that on December 11, 2014, a complete and entire copy of this Petition for Inter

Partes Review and all supporting exhibits were provided via FEDEX

STANDARD OVERNIGHT and email, costs prepaid, to the Patent Owner by

serving the correspondence address of record as follows:

MiMedx Group, Inc. c/o Foley & Lardner LLP 3000 K Street N.W. Suite 600 Washington DC 20007-5109

MiMedx Group, Inc. c/o ALSTON & BIRD LLP Dwayne C. Norton 2828 North Harwood St Suite 1800 Dallas, TX 75201 [email protected]

By: /Robert L. McRae, Reg. No. 53309/ Robert L. McRae, Reg. No. 53309 GUNN, LEE & CAVE, P.C. 300 Convent St., Suite 1080 San Antonio, TX 78205 Phone: (210) 886–9500 Fax: (210) 886–9883

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BEFORE THE PATENT TRIAL AND APPEAL BOARD TISSUE …knobbemedical.com/.../2014/12/IPR-Petition-for-U.S.... · Petitioners are the real parties-in-interest for this petition. B. Standing